Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Firstkind Limited — Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

78 daysmedian FDA review time

153 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K220327	geko W-3	Firstkind Limited	2022-03-04	28
K212762	geko W-2	Firstkind Limited	2021-11-29	90
K201131	firefly T-2	Firstkind Limited	2020-05-28	30
K193045	geko™ W-2	Firstkind Limited	2020-01-18	78
K191113	geko T-2 and geko T-3 Neuromuscular Stimulators	Firstkind Limited	2019-09-18	145
K181059	geko T-3 Neuromuscular Stimulator	Firstkind Limited	2018-05-23	30
K163125	geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators	Firstkind Limited	2017-04-10	153
K160299	geko(TM) Plus R-2 Neuromuscular Stimulator	Firstkind Limited	2016-04-08	64
K152677	geko T-2 Neuromuscular Stimulator	Firstkind Limited	2015-10-23	35
K133638	GEKO	Firstkind Limited	2014-08-21	267
K134001	FIREFLY	Firstkind Limited	2014-05-15	139

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda